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Sorafenib in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Sunitinib or Bevacizumab

Primary Purpose

Kidney Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

sorafenib tosylate

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring clear cell renal cell carcinoma, recurrent renal cell cancer, stage IV renal cell cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

Histologically confirmed renal cell carcinoma with a component of clear cell histology
- Metastatic disease
Disease progression, as defined by RECIST criteria, after prior treatment with sunitinib malate or bevacizumab
- Patients must have received ≥ 1 course (4 weeks) of sunitinib malate or ≥ 2 doses of bevacizumab AND have RECIST-defined objective progression during or within 4 months after completing treatment with sunitinib malate or bevacizumab
Measurable disease by RECIST criteria
CNS metastases allowed provided patient has undergone prior surgery and/or radiotherapy AND has no evidence of further CNS disease progression by CT scan or MRI ≥ 2 weeks after treatment of CNS metastases

PATIENT CHARACTERISTICS:

ECOG performance status (PS) 0-1 or Karnofsky PS 70-100%
WBC ≥ 3,000/μL
Absolute neutrophil count ≥ 1,500/μL
Platelet count ≥ 75,000/μL
Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
AST/ALT ≤ 2.5 times ULN
Creatinine ≤ 2.0 times ULN
Negative pregnancy test
No significant cardiovascular disease, including any of the following:
- Congestive heart failure (New York Heart Association class III-IV heart disease)
- Active angina pectoris requiring nitrate therapy
- Uncontrolled dysrhythmias
- Cardiovascular event within the past 6 months (e.g., transient ischemic attack/cerebrovascular accident, myocardial infarction, or vascular surgery)

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
At least 2 weeks since prior systemic therapy, radiotherapy, or major surgery and recovered
No prior sorafenib tosylate
No other concurrent investigational agents
No other concurrent anticancer therapy
No concurrent prophylactic growth factors

Sites / Locations

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Baylor Sammons Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sorafenib

Arm Description

Chemotherapy single agent systemic. Sorafenib given up to 600mg orally every 12 hours for up to 10 months (40 weeks).

Outcomes

Primary Outcome Measures

Tumor Burden Reduction Rate (TBRR)

The primary endpoint of the study is defined as the percentage of patients who experience larger than or equal to 5% reduction in tumor burden as measured by RECIST-defined target lesions without progression of non-target lesions or the appearance of any new lesions, confirmed at least 4 weeks after first documentation. RECIST criteria will be used for the purpose of designating target lesions, calculating total tumor burden (the sum of the unidimensional measurement of target lesions) and defining disease progression.Additional RECIST-defined partial or complete responses will be recorded.

Secondary Outcome Measures

Overall Survival

Overall survival measured in months and summarized using the Kaplan-Meier method. This will be calculated from the date of registration on-study to the dates of documented evidence of progression and death, respectively.

Time to Progression

Time to objective progression will be measured from the start of treatment until the criteria for RECIST-defined progression are met, taking as reference the smallest measurements recorded since the treatment started, including baseline. Progression-free survival measured in months and summarized using the Kaplan-Meier method.

Duration of Overall Response (Tumor Burden Reduction)

Measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.

Full Information

NCT ID

NCT00866320

First Posted

March 19, 2009

Last Updated

July 14, 2014

Sponsor

Case Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00866320

Brief Title

Sorafenib in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Sunitinib or Bevacizumab

Official Title

A Phase II Study of Sorafenib in Patients With Metastatic Renal Cell Carcinoma (RCC) Refractory to SU11248 or Bevacizumab Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

February 2006 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Case Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with metastatic kidney cancer that has not responded to sunitinib or bevacizumab.

Detailed Description

OBJECTIVES: Primary To determine the tumor burden reduction rate in patients with sunitinib malate- or bevacizumab-refractory, metastatic clear cell renal cell carcinoma treated with sorafenib tosylate. Secondary To determine the safety of sorafenib tosylate in these patients. To record the duration of tumor reduction, time to disease progression, and overall survival of patients treated with sorafenib tosylate. OUTLINE: Patients receive oral sorafenib tosylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Cancer

Keywords

clear cell renal cell carcinoma, recurrent renal cell cancer, stage IV renal cell cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sorafenib

Arm Type

Experimental

Arm Description

Chemotherapy single agent systemic. Sorafenib given up to 600mg orally every 12 hours for up to 10 months (40 weeks).

Intervention Type

Drug

Intervention Name(s)

sorafenib tosylate

Intervention Description

Sorafenib (BAY 43-9006) is an oral multi-kinase inhibitor targeting both tumor cells and the tumor vasculature. Patients with metastatic RCC meeting eligibility criteria will receive 400 mg BID of sorafenib in a single-arm phase II study. Treatment will be administered on an outpatient basis.

Primary Outcome Measure Information:

Title

Tumor Burden Reduction Rate (TBRR)

Description

Time Frame

at 8 weeks (2cycles of treatment)

Secondary Outcome Measure Information:

Title

Overall Survival

Description

Time Frame

followed until progression or death for approximately 3 years

Title

Time to Progression

Description

Time Frame

followed to progression for approximately 3 years

Title

Duration of Overall Response (Tumor Burden Reduction)

Description

Measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.

Time Frame

followed for overall response for approximately 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically confirmed renal cell carcinoma with a component of clear cell histology Metastatic disease Disease progression, as defined by RECIST criteria, after prior treatment with sunitinib malate or bevacizumab Patients must have received ≥ 1 course (4 weeks) of sunitinib malate or ≥ 2 doses of bevacizumab AND have RECIST-defined objective progression during or within 4 months after completing treatment with sunitinib malate or bevacizumab Measurable disease by RECIST criteria CNS metastases allowed provided patient has undergone prior surgery and/or radiotherapy AND has no evidence of further CNS disease progression by CT scan or MRI ≥ 2 weeks after treatment of CNS metastases PATIENT CHARACTERISTICS: ECOG performance status (PS) 0-1 or Karnofsky PS 70-100% WBC ≥ 3,000/μL Absolute neutrophil count ≥ 1,500/μL Platelet count ≥ 75,000/μL Total bilirubin ≤ 1.5 times upper limit of normal (ULN) AST/ALT ≤ 2.5 times ULN Creatinine ≤ 2.0 times ULN Negative pregnancy test No significant cardiovascular disease, including any of the following: Congestive heart failure (New York Heart Association class III-IV heart disease) Active angina pectoris requiring nitrate therapy Uncontrolled dysrhythmias Cardiovascular event within the past 6 months (e.g., transient ischemic attack/cerebrovascular accident, myocardial infarction, or vascular surgery) PRIOR CONCURRENT THERAPY: See Disease Characteristics At least 2 weeks since prior systemic therapy, radiotherapy, or major surgery and recovered No prior sorafenib tosylate No other concurrent investigational agents No other concurrent anticancer therapy No concurrent prophylactic growth factors

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brian I. Rini, MD

Organizational Affiliation

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

Baylor Sammons Cancer Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Sorafenib in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Sunitinib or Bevacizumab

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